SYNERMED IR 200 CHEMISTRY ANALYZER— 510(k) K971491

Name: FDA 510(k) clearance K971491
Creator: U.S. Food and Drug Administration
Published: 1997-06-26

Substantially Equivalent

Synermed, Inc.

FDA 510(k) clearance K971491 for SYNERMED IR 200 CHEMISTRY ANALYZER, Substantially Equivalent on 1997-06-26. Applicant: Synermed, Inc.. Device class: 1.

Clearance details

Applicant: Synermed, Inc.
Product code: Code JJF
Device class: Class 1
Regulation: 21 CFR 862.2170
Advisory panel: Clinical Chemistry
Date received: 1997-04-24
Decision date: 1997-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, Canada, CA

Download summary PDF View on FDA.gov ↗

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